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Sponsored by: |
Scottish Cancer Therapy Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003012 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in treating women who have early stage breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: CMF regimen Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer |
Estimated Enrollment: | 1000 |
Study Start Date: | October 1996 |
OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant chemotherapy in women with node positive early breast cancer, as measured by overall and event free survival from the date or randomization.
II. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by quality of life.
OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed, early stage, unilateral invasive breast cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node metastases OR Lymph node negative Not locally advanced If supraclavicular node is enlarged or suspicious of metastasis, negative biopsy for supraclavicular node metastases required No evidence of any other metastases clinically or on routine staging investigations No past history of pure in situ carcinoma in either breast Primary tumor is completely excised
PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Performance status: Not specified Hematopoietic:
Neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 No evidence of sepsis Hepatic:
Adequate hepatic function Bilirubin normal AST/ALT normal Renal: Adequate renal function Creatinine less than 1.2 mg/dL Cardiovascular: No clinically significant cardiovascular disease Other: No prior or concurrent other malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior tamoxifen allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
United Kingdom | |
Ayr Hospital | |
Ayr, United Kingdom, KA6 6DX | |
Falkirk Royal Infirmary | |
Falkirk, United Kingdom, FK1 5RE | |
United Kingdom, England | |
University Hospitals of Leicester | |
Leicester, England, United Kingdom, LE1 5WW | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Beatson Oncology Centre | |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
Raigmore Hospital | |
Inverness, Scotland, United Kingdom, 1V2 3UJ | |
Royal Alexandra Hospital | |
Paisley, Scotland, United Kingdom | |
University of Glasgow | |
Glasgow, Scotland, United Kingdom, G61 1BD | |
Ninewells Hospital and Medical School | |
Dundee, Scotland, United Kingdom, DD1 9SY |
Study Chair: | Chris Twelves, MD, BMedSci, FRCP | University of Glasgow |
Study ID Numbers: | CDR0000065590, SCTN-BR9601, EU-97013 |
Study First Received: | November 1, 1999 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00003012 History of Changes |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IIIA breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Adjuvants, Immunologic Folate Breast Neoplasms Cyclophosphamide Folinic Acid Folic Acid Antagonists Epirubicin |
Immunosuppressive Agents Vitamin B9 Folic Acid Anti-Bacterial Agents Fluorouracil Methotrexate Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Alkylating Agents |
Nucleic Acid Synthesis Inhibitors Breast Diseases Skin Diseases Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Epirubicin Pharmacologic Actions Neoplasms Fluorouracil Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |